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Prognostic Value of Circulating Endothelial Progenitor Cells in Aneurysmal Subarachnoid Hemorrhage (EVAPROPEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Centre Hospitalier Universitaire de Besancon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01773200
First received: January 18, 2013
Last updated: May 21, 2014
Last verified: November 2012
  Purpose

Aneurysmal subarachnoid hemorrhage is a common and serious disease associated to a high rate of mortality and morbidity. Severe definitive neurological impairment can concern up to 30% of patients in relation with elevated intracranial pressure, hemorrhage recurrence and symptomatic cerebral arterial vasospasm. This latter complication is defined as a reversible reduction of cerebral artery's diameter occurring between the 4th and the 14th day after bleeding. Physiopathology is not well understood, but could involve endothelium, trough endothelial progenitor cells (EPC). Circulating EPC are bone marrow-derived cells with capacity of vasculogenesis and angiogenesis. EPC have been recognized playing a beneficial role in cardiovascular disease and ischemic stroke. EPC have never been studied in aneurysmal subarachnoid hemorrhage.

The primary objective of this study is to compare the number of circulating endothelial progenitor cells between patients with a good neurological outcome (defined as a glasgow outcome scale = 1 or 2) and patients with a poor neurological outcome (glasgow outcome scale = 3, 4 or 5).

Briefly, the number of circulating EPC will be measured at admission, and at day 3, 6, 10, 14, 21 in each consecutive patient suffering aneurysmal subarachnoid hemorrhage and hospitalized in Teaching Hospital of Besançon (France). The neurological outcome will be measured one year after subarachnoid hemorrhage.


Condition
Aneurysmal Subarachnoid Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Circulating Endothelial Progenitor Cells in Aneurysmal Subarachnoid Hemorrhage (Evaluation de l'intérêt Pronostic Des progéniteurs endothéliaux Circulants Dans l'hémorragie Sous-arachnoïdienne Par Rupture d'anévrysme cérébral)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • endothelial progenitor cells count [ Time Frame: day 3 after bleeding ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial progenitor cells count [ Time Frame: day 0, 6, 10, 14, 21 after bleeding ] [ Designated as safety issue: No ]
  • Maximal amplitude of variation of EPC count [ Time Frame: 3 weeks after bleeding ] [ Designated as safety issue: No ]
  • Plasmatic brain natriuretic peptide [ Time Frame: day 0, 3, 6, 10, 14, 21 after bleeding ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Glasgow Outcome Scale [ Time Frame: One year after bleeding ] [ Designated as safety issue: No ]
  • Vasospasm occurence [ Time Frame: during the 3 weeks after bleeding ] [ Designated as safety issue: No ]

    Vasospasm will be defined as at less one segmental narrowing of a cerebral artery diagnosed on cerebral angiography (angio scanner, angio-MRI or 4 axes cerebral arteriography). Cerebral angiography will be done as necessary according to the occurence of the following situations

    • a clinical neurological deterioration unexplained by another cause
    • a mean arterial blood flow speed higher than 2 m/s assessed in cerebral arteries by transcranial doppler or a significant elevation of the mean arterial blood flow speed on two consecutive evaluations


Estimated Enrollment: 92
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Aneurysmal Subarachnoid Hemorrhage
Each consecutive patient suffering from aneurysmal subarachnoid hemorrhage

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients suffering from acute aneurysmal subarachnoid haemorrhage. .

Criteria

Inclusion Criteria:

  • recent(< 24 h) aneurysmal subarachnoid hemorrhage
  • written informed consent obtained from the patient or from close relatives

Exclusion Criteria:

  • refusal to participate
  • Non-aneurysmal subarachnoid hemorrhage
  • aneurysmal subarachnoid hemorrhage with estimated date of bleeding > 24 h
  • Chronic heart failure
  • Chronic medication able to modify the plasmatic level of BNP
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773200

Contacts
Contact: Sébastien Pili-Floury, MD, PhD +33 3 81 66 85 79 spilifloury@orange.fr

Locations
France
CHRU de Besançon Recruiting
Besançon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Sébastien Pili-Floury, MD, PhD CHRU de Besançon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01773200     History of Changes
Other Study ID Numbers: P/2012/153
Study First Received: January 18, 2013
Last Updated: May 21, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire de Besancon:
endothelial progenitor cells
aneurysmal subarachnoid hemorrhage
vasospasm
BNP

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014